Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke

Not Applicable

Active, not recruiting

• Conditions: Acute Stroke; Cerebral Hemorrhage; Blood Pressure
• Interventions: Device: Clearsight device (Edwards) around the finger; Device: Intermittent blood pressure measurements with cuff.

• Registration Number: NCT03359434
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

A monocentric, non-randomized, prospective study in which each patient is his/her own control.

The study investigates 2 methods of blood pressure measurement, within the first 24 hours after reperfusion, i) Continuous measurement of blood pressure with the Clearsight device (Edwards) and ii) intermittent blood pressure measurements with cuff.

Detailed Description

Patients will be followed for 72 hours:

* inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure.

* within 24 hours after reperfusion: blood pressure measurements

* at 24 hours: NIHSS score.

* Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes).

* 72 hours after reperfusion: brain scanner in case of hyperdensity on the initial scanner

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-02
• Study Start: 2018-12-05
• Status Verified: 2023-12
• Primary Completion: 2023-12-17
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26
• Study Completion: 2024-12-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

• Occlusion of internal carotid arteries or proximal middle cerebral arteries (segment M1).
• Reperfusion after a thrombectomy procedure (defined by a 2b-3 Thrombolysis In Cerebral Infarction (TICI) score).

Exclusion Criteria

• Per-procedure hemorrhagic complications (prior to reperfusion)
• Known pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Two measuring methods of blood pressure	Clearsight device (Edwards) around the finger	-
Two measuring methods of blood pressure	Intermittent blood pressure measurements with cuff.	-

Primary Outcome Measures

Name	Time	Method
Occurence of intracranial hemorrhagic complications	36 hours after baseline	number of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading

Trial Locations

Locations (1)

Fondation Ophtalmologique A de Rothschild; 🇫🇷 Paris, France